DIAGNOSTIC ULTRASOUND

Ultrasound has been used in medicine since 1951 for diagnostic purposes. In imaging applications, ultrasound is sent to tissues and returns an echo. The recording of the returned echo allows for the creation of ultrasound images. Since the initial development of ultrasound imaging, the principle has remained the same, but systems have improved with advancements in computing power and the arrival of Doppler, 3D imaging, and recently elastography. The power of the ultrasound energy sent to the tissue for imaging is very low in order to not induce any tissue damage.

THERAPEUTIC ULTRASOUND

If ultrasound is emitted with a power increased by a factor of 10, it becomes capable of inducing tissue heating that can either activate or destroy the cells. Ultrasound for thermal therapy is called High Intensity Focused Ultrasound (HIFU). In order to not destroy all of the tissues in the path of the ultrasound beam, the ultrasonic waves are emitted by a large aperture transducer and converge at a focal point, where the intensity is 10-1000 times higher than along the path. HIFU is in clinical development for the destruction of tumors throughout the body, including in the prostate, liver, brain, and breast.

The application of HIFU to the brain currently poses a significant problem: the skull limits the passage of ultrasound energy. The skull absorbs about 80% of the emitted energy. In addition, the inhomogeneous nature of the skull leads to a defocusing of the waves and therefore a loss of the focal spot. CarThera® has managed to avoid the problem of the skull bone by using devices that deliver ultrasound energy directly to the brain tissue, without traversing the bone.

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Pascal Girin brings wealth of experience in medical device and life sciences industries to support CarThera’s future growth. Girin has decades of business expertise in the life sciences and medical devices markets, most recently as CEO of Balt, a leader in the treatment of neurovascular diseases. Prior to this, he held numerous C-level positions at leading medical companies, including Wright Medical, Keystone Dental (a Warburg Pincus company), EV3, Baxter and Ohmeda, among others. As chairman of CarThera’s board of directors, he will bring invaluable insight to the company’s business strategy and future development.

Final results of the phase I/IIa clinical trial (NCT02253212) on the ultrasound-induced blood-brain barrier (BBB) opening improving the efficiency of carboplatin chemotherapy for recurrent glioblastoma patients were published in AACR’s Clinical Cancer Research journal of the . Study results show a good safety profile and encouraging efficacy. These results are based on 65 sonication sessions with escalating ultrasound pressure levels. GBM patients treated with optimal pressure levels and MRI-detected disrupted BBB (11 patients) showed a median progression-free survival (PFS) of 4.11 months and a median overall survival (OS) of 12.94 months. This compares to 2.73 months and 8.64 months respectively, for GBM patients without BBB disruption (8 patients).

€9M ($10.3M) was raised with three institutional investors, Panakès Partners, Sham Innovation Santé (advised by Turenne Capital) and Supernova Invest via its fund Supernova 2, as well as Group Arnault and historical investors. The proceeds will be used to further advance the SonoCloud technology and develop the clinical pipeline of the company. A multi-center study has already been launched in France and in the US to evaluate the SonoCloud-9 device, a new generation of implant with nine ultrasound emitters, in patients with recurrent glioblastoma. The company also has an on-going clinical study with the SonoCloud-1 device in patients with Alzheimer’s disease and one planned for patients with brain metastases.